BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO ENTERAL FEEDING TUBE

    MDR report key: 13505575 · Received February 10, 2022

    Report

    Report Number
    13505575
    Event Type
    Malfunction
    Date Received
    February 10, 2022
    Date of Event
    February 12, 2021
    Report Date
    February 2, 2022
    Manufacturer
    CORPAK MEDSYSTEMS, INC.
    Product Code
    KNT
    UDI-DI
    10815149020539
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NOTICEABLE DEFECT IN FEEDING TUBE SHOWED UP ON X-RAY. FIRST THOUGHT TO BE KINK THEN APPEARED TO BE A FRACTURE. ENTERIC TUBE REMOVED, FOUND TO BE INTACT, BUT LARGE WEAK SPOT/BALLOONING NOTED NEAR DISTAL END. A NEW FEEDING TUBE WAS SUBSEQUENTLY PLACED. THIS TUBE WAS IN AN INFANT. PICTURES AVAILABLE UPON REQUEST. THE TUBE COULD HAVE RUPTURED AND PORTION BEEN RETAINED IN THE STOMACH, WHICH WOULD HAVE REQUIRED ENDOSCOPY OR SURGERY FOR RETRIEVAL. AVANOS HAS BEEN CONTACTED REGARDING ISSUE. HAVE NOT RECEIVED RESULTS FROM ANALYSIS YET BUT THERE HAS NOT BEEN ANY ADDITIONAL PRODUCT REPORTS ISSUED ON THIS PRODUCT.

    Description of Event or Problem · 0

    NOTICEABLE DEFECT IN FEEDING TUBE SHOWED UP ON X-RAY. FIRST THOUGHT TO BE KINK THEN APPEARED TO BE A FRACTURE. ENTERIC TUBE REMOVED, FOUND TO BE INTACT, BUT LARGE WEAK SPOT/BALLOONING NOTED NEAR DISTAL END. A NEW FEEDING TUBE WAS SUBSEQUENTLY PLACED. THIS TUBE WAS IN AN INFANT. PICTURES AVAILABLE UPON REQUEST. THE TUBE COULD HAVE RUPTURED AND PORTION BEEN RETAINED IN THE STOMACH, WHICH WOULD HAVE REQUIRED ENDOSCOPY OR SURGERY FOR RETRIEVAL. AVANOS HAS BEEN CONTACTED REGARDING ISSUE. HAVE NOT RECEIVED RESULTS FROM ANALYSIS YET BUT THERE HAS NOT BEEN ANY ADDITIONAL PRODUCT REPORTS ISSUED ON THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796374 CORFLO ENTERAL FEEDING TUBE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CORPAK MEDSYSTEMS, INC. 42-1365 77296 10815149020539

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown